STOPCOCKS & EXTENSION TUBES— 510(k) K840394

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K840394 for STOPCOCKS & EXTENSION TUBES, Substantially Equivalent on 1984-03-19. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1984-01-30
Decision date: 1984-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.